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Recruiting NCT06909604

Al18F-HER2-BCH PET in Breast Patients Treated With ADC Therapy

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HER2 expression of PET imaging.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Al18F-HER2-BCH PET/CT to Predict Response in Breast Patients Treated With ADC Therapy

Overview

To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with ADC therapy

Interventions

  • Radiation HER2 expression of PET imaging
    Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in breast patients treated with ADC therapy

Primary outcome measures

  • Changes in SUVmax before and after treatment [Time frame: Before treatment, 9 weeks after treatment, before surgery]

Eligibility criteria

Inclusion criteria

  • Aged ≥18 years old; ECOG 0 or 1;
  • Patients with HER2 positive or low tumors;
  • Receives neoadjuvant therapy
  • Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
  • Life expectancy > 3 months -

Exclusion criteria

  • Significant hepatic or renal dysfunction;
  • Is pregnant or ready to pregnant;
  • Cannot keep their states for half an hour;
  • Refused to join the clinical research;
  • Suffering from claustrophobia or other mental disorders;
  • Any other situation that researchers considered it unsuitable to participate in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Peking University Cancer Hospital & Institute — Beijing

Identifiers

NCT: NCT06909604 · 2019KT114-ZY02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗